510(k) · Cleared
Recalled · Class II · 2020Neurosign Model 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Magstim Company, Ltd. · ETN Stimulator, Nerve
Cleared on Nov 24, 1992 after a 153-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 45 later devices descend from it. It has been recalled once.
- Decided
- Nov 24, 1992
- Review
- 153 days
- Class
- Class II
- Product code
- ETN
- Recalls
- 1
- Predicates
- 0
45 later devices descend from it, 1 citing it directly.
- This deviceK923056 Neurosign Model 100The Magstim Company, Ltd. · 1992
- Descendant · cites it directly · 44 of its ownK991583 Neurosign 400, 4 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1999
- Descendant · 2 generations on · 38 of its ownK050325 Disposable Concentric Probe, Disposable Bipolar Probe, Disposable…Technomed Europe · 2005
- Descendant · 3 generations on · 32 of its ownK062996 Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc. · 2007
- Descendant · 4 generations on · 19 of its ownK090838 Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009
- Descendant · 4 generations on · 19 of its ownK063729 Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe · 2007
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K991583Neurosign 400, 4 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1999 · cites it directly44descendants
- K050325Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar ProbeTechnomed Europe · 2005 · 2 generations on38descendants
- K062996Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc. · 2007 · 3 generations on32descendants
- K090838Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009 · 4 generations on19descendants
- K063729Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe · 2007 · 4 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923056 | Neurosign Model 100 | The Magstim Company, Ltd. | 1992 | — |
| +1 | K991583 | Neurosign 400, 4 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1999 | — |
| +2 | K050325 | Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar… | Technomed Europe | 2005 | — |
| +3 | K062996 | Disposable Monopolar and Bipolar Stimulator Probes | Axon Systems, Inc. | 2007 | — |
| +4 | K090838 | Stimulus/Dissection Instruments | Axon Systems, Inc. | 2009 | — |
| +4 | K063729 | Disposable Pedicle Screw Probe, Model 3603-00 | Technomed Europe | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ETN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ETN device
- #1 K251672 NIM Essence™ EMG Endotracheal Tube…score 12.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (45)
See all 451 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991583 | Neurosign 400, 4 Channel Motor Nerve Monitor | 1999 | 44 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 8, 2020 | Class II | Z-0869-2021 | Process control | A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being configured appropriately for the supply mains within the target Country. The specific deficiency includes: 1. Onboard voltage selector… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K991583 (The Magstim Company, Ltd., 1999) has gone furthest, with 44 descendants of its own.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ETN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ETN
98in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ETN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ETN
1,145in 2025
MAUDE reports naming product code ETN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 5 |
| 2008 | 2 | — | 1 | 5 |
| 2009 | 5 | 115 | 0 | 22 |
| 2010 | 3 | 168 | 1 | 26 |
| 2011 | 9 | 115 | 0 | 55 |
| 2012 | 7 | 179 | 0 | 187 |
| 2013 | 1 | — | 0 | 270 |
| 2014 | 2 | — | 0 | 137 |
| 2015 | 1 | — | 0 | 202 |
| 2016 | 2 | — | 1 | 145 |
| 2017 | 0 | — | 0 | 117 |
| 2018 | 0 | — | 0 | 250 |
| 2019 | 0 | — | 2 | 314 |
| 2020 | 1 | — | 1 | 238 |
| 2021 | 1 | — | 1 | 197 |
| 2022 | 2 | — | 0 | 247 |
| 2023 | 5 | 98 | 1 | 390 |
| 2024 | 2 | — | 0 | 748 |
| 2025 | 1 | — | 0 | 1,145 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K923056 · printed Nov 5, 2026
Cite this page
510(k) Report. “K923056: Neurosign Model 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K923056
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026